Creates provisions relating to ibogaine treatment
Missouri would fund FDA-supervised ibogaine trials for veterans’ opioid and mental health issues through dedicated grants and two non-reverting funds, with strict oversight.
Missouri would fund FDA-supervised ibogaine trials for veterans’ opioid and mental health issues through dedicated grants and two non-reverting funds, with strict oversight.
Overview
- Purpose: Establish a structured, FDA-supervised framework to fund and conduct ibogaine clinical drug development trials for opioid use disorder, co-occurring substance use disorders, and other neurological or mental health conditions, with a specific focus on veterans.
- Jurisdiction: Missouri
- Key mechanism: Creation of dedicated funds and grant programs administered by the Department of Health and Senior Services (DHSS), supported by non-reverting state funds and private contributions.
Main Goals and Intent
- Bring FDA-overseen ibogaine research and clinical trials to Missouri institutions.
- Target illnesses that disproportionately affect veterans, including opioid use disorder, PTSD-related conditions, and other mental health challenges.
- Create dedicated funding streams to support research, while ensuring safety, accountability, and transparency through reporting requirements.
Substantive Provisions and Changes
- Authorization of Grants (Section 191.1616)
- The DHSS may award grants (subject to appropriation) to conduct certified FDA-supervised clinical drug development trials on ibogaine and its analogs.
- Eligible applicants must be located in Missouri and meet several criteria related to neurological research, neurosurgery capacity, research capability, and commitment to matching funds from non-state sources.
- Applicants must have an agreement with a multistate consortium established by another state government that:
- Has submitted an IND to FDA (21 CFR Part 312).
- Has requested FDA Breakthrough Therapy designation for ibogaine (21 U.S.C. § 356).
Funding and Governance
Intellectual Property and Revenue (Section 191.1622)
Clinical Practice and Oversight (Section 191.1625)
Reporting and Accountability (Section 191.1619)
Miscellaneous Implementation Notes
Estimated Fiscal Impact (per legislative fiscal note)
- General Revenue impact: Net positive, with potential gains in revenue through appropriations to the Ibogaine Study Fund and related matching funds. Projected net effect ranges across years show substantial potential increasing general revenue if the program is funded at stated levels.
- Grant costs: Estimated to be $6–8 million for Phase I (FY27), $15–25 million for Phase II (FY28–29), and $60–180 million for later phases (FY30+), subject to appropriations and the number of trials.
- Staffing: About 5 FTEs in DHSS to administer the program.
- Funds: Creation of two dedicated funds (Ibogaine Study Fund and Ibogaine Intellectual Property Fund); funds are non-reverting and dedicated to their respective purposes.
Audience and Affected Parties
- Primary: Missouri veterans and veterans' service organizations (with a focus on mental health and substance use conditions).
- Research institutions in Missouri, particularly those with neurosurgery and clinical trial capabilities.
- Physicians and hospitals licensed in Missouri.
- Private partners and consortia engaged in FDA-regulated ibogaine research.
Timeline Highlights
- Grant applications to begin before November 1, 2026.
- Ongoing quarterly and annual reporting requirements to the DHSS and General Assembly.
- Potential Phase I start in FY2027, Phase II in FY2028–FY2029, with Phase III contingent on FDA progression (not expected until 2030+).
Notes and Considerations
- The program links Missouri funding to externally governed, out-of-state consortia and FDA processes, introducing governance and compliance risk if partnering entities or IND status change.
- The proposal emphasizes veteran-focused outcomes and a regulated research pathway rather than broad legalization or recreational use.
- Several stakeholders (e.g., Missouri State Medical Association) have raised concerns about safety, liability, and regulatory dependencies.
This summary captures the bill’s core structure, funding architecture, and its intended impact on veteran mental health research through FDA-approved ibogaine trials.
Compiled from official sources — confirm details with the bill’s official record.
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